OTCQB: ARTL Investor Presentation | July 2018 - Artelo Biosciences
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A clinical stage biopharmaceutical company developing and commercializing a portfolio of novel therapeutic candidates targeting the endocannabinoid system OTCQB: ARTL Investor Presentation | July 2018
Forward Looking Statements
Statements in this Artelo Biosciences presentation that are not historical facts are "forward-looking statements" subject to
risks/uncertainties. Such statements are based on current facts/analyses and other information that are based on forecasts of results,
estimates of amounts not yet determined, and assumptions of management. Such statements are generally, but not always, identified
by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", and similar expressions or that events or conditions
"will", "would", "may", "can", "could" or "should" occur. Information concerning reserve estimates may also be deemed to be forward
looking statements, as it constitutes a prediction of what might be present when/if a project is actually developed.
It is important to note that actual outcomes and results could differ materially from those in such statements due to numerous factors
beyond the Company's control including misinterpretation of data, inaccurate estimates of timelines, uncertainty of the requirements
demanded by governmental agencies, Company's ability to raise financing, breach by third-parties, inability to retain
employees/consultants, competition for equipment, inability to obtain permits, delays in operations, problems with licensing
agreements, the likelihood that no commercial markets exist for our products, and our ability to develop products.
This presentation does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United
States. The securities mentioned herein have not been, and will not be, registered under the Securities Act of 1933, as amended. They
may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities
Act. Company undertakes no obligation to publicly release the results of any revisions to these statements that may be made to reflect
the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
2
Company Highlights
NOVEL DRUG ROBUST NEAR-TERM HIGH-GROWTH PROVEN
PIPELINE PATENT ESTATE MILESTONES SECTOR LEADERSHIP TEAM
Portfolio approach Comprehensive Upcoming IP, pre- Cannabis-based Experienced team of
to endocannabinoid issued and pending clinical milestones Pharmaceutical pharmaceutical
system modulation intellectual property and initiation of Market is expected to executives and
provides multiple clinical studies over surpass $20 billion by cannabinoid researchers
“shots on goal” Broad claims assure the next 12 months 2020 with proven track
meaningful market records developing and
Developing best-in- exclusivity commercializing
class therapeutics federally regulated
from leading edge drugs
science
3
Using Endocannabinoid System (ECS) Modulation to Improve Health
The ECS is a family of receptors and neurotransmitters that form a
biochemical communication network throughout the body
▪ Primary receptors of the ECS are CB1 and CB2
▪ Receptors located in the central and peripheral nervous systems
▪ Endocannabinoids and cannabinoids can penetrate the blood-brain
barrier
▪ The ECS is involved in regulating a variety of physiological and
cognitive processes
▪ Emerging science suggests ECS modulation may be relevant to
multiple diseases and medical conditions
The ECS is widely distributed
throughout the human body
4
Three Primary Approaches to Modulating the ECS
Modulating the ECS can be accomplished through several treatment strategies
▪ Naturally occurring cannabinoids are
chemical compounds that exist in nature Naturally
Occurring
▪ Synthetic cannabinoids are small Cannabinoids
molecules with cannabinoid-like activities
Endo-
Synthetic
▪ Endocannabinoid modulators are
Cannabinoids
cannabinoid
molecules that aim to regulate the Modulators
cannabinoids produced in the body
5
Development Pipeline
Product Candidate Pre-clinical Phase 1 Phase 2 Expected Milestones
Start Phase 1b/2a study
Anorexia / Cachexia in anorexia associated
ART 27.13 with cancer in 2019
Dual CB1/CB2 Agonist Cancer cell line screen
Anti-Cancer
data readout Q3 2018
Planning pre-IND
ART 12.11 Inflammatory Bowel meeting with FDA to
initiate human studies
Proprietary Cannabidiol
(CBD) Rare Diseases Patent issues in 2019
Prostate Cancer
ART 26.12 Initiate IND-enabling
studies in 2019
FABP5 Inhibitor Breast Cancer
6
Patent Estate Offers Significant Market Exclusivity Potential
Product Candidate Patents Term Potential Addressable Market*
Anorexia: 60% of people treated for
NOV 2025 cancer
ART 27.13 Multiple issued patents in
US and ex-US covering
Potential extension through Lung cancer: $6.2B (target market will
Dual CB1/CB2 Agonist composition of matter
MAY 2031 depend upon readout of pre-clinical
evidence)
Composition of matter
ART 12.11 patent application with
broad claims
Patent pending (expecting
to be issued in 2019)
IBD (Crohn’s and Colitis): $9B
Proprietary Cannabidiol Stroke: $4B
(CBD) Product by process Planned filing in 2H 2018
Rare diseases $1.2B
application
Multiple issued and
pending applications
ART 26.12 Covers the target,
Applications filed during
Breast Cancer $13B
FABP5 Inhibitor composition of matter,
2009 through 2017
Prostate Cancer $8.2B
and utility claims
*Global therapeutics market based upon total annual Rx sales or treatable population in 2016 (unless otherwise specified). References on file and available upon request.
7
ART 12.11 PROPRIETARY COCRYSTAL CBD PROGRAM
CBD’s Protection Challenge for Pharmaceutical Development
ARTART
• CBD was FDA approved in June 2018
•
12.11
The US CBD market is projected to approach $3B in 2021*
12.11 PROPRIETARY
• CBD is in the public domain
PROPRIETARY
• Market exclusivity strategies used by others
• Delivery method (proprietary patch, spray, ointment, chewing gum, etc.)
• Derivative manipulation (change the molecule to create new chemical entity)
• Development in a narrow disease (Orphan Drug protection and discrete use patents)
• Artelo’s solution: based upon cocrystalization; a well-developed and established pharmaceutical strategy
COCRYSTAL
COCRYSTAL
• A pharmaceutical cocrystal of CBD offers Artelo the exclusive opportunity to:
• 1) Develop a cannabidiol-based drug product with the potential for improved safety and efficacy
• 2) Establish a strong proprietary position as cocrystals are viewed as patentable subject matter
CBD COMPOSITION
• In 2017, Artelo filed a patent application for ART12.11 with broad claims
CBD PROGRAM
• Artelo currently conducting IND-enabling studies and planning to discuss with FDA a pathway to approval
*https://www.forbes.com/sites/debraborchardt/2016/12/12/the-cannabis-market-that-could-grow-700-by-2020/#5667fb784be1.
9
ART12.11 Cannabidiol (CBD) Cocrystal: The Same and Different
ARTART
The Same - US FDA perspective: Cocrystals can be engineered to enhance bioavailability, stability and improve
chemical processing. Essentially, they can be viewed as a new polymorph of the Active Pharmaceutical Ingredient
12.11
and the same pharmacologically.
12.11 PROPRIETARY
Different - US Patent Office perspective: Cocrystals can be new and distinct solid state forms that satisfy the
requirements for novelty, utility and non-obviousness for a composition of matter claim. Distinct pharmaceutically.
PROPRIETARY
Isolated from Nature Synthetically Created ART12.11 Cocrystal
CBD - Active Pharmaceutical
COCRYSTAL
Ingredient
COCRYSTAL
Composition of Matter Patent
None None Pending
Protection
None identified
CBD COMPOSITION
Problematic Polymorphism Inherent Inherent
(single polymorph)
CBD PROGRAM
Improved stability
Expected Superiority Natural Purity Consistency in absorption
Increased safety / efficacy
10ART 27.13 CANCER / ANOREXIA CLINICAL PROGRAM
ART27.13 – Cannabinoid Agonist that Targets the Body not the Brain
ART 27.13
• Peripherally restricted, highly-potent, synthetic
agonist that enables systemic metabolic effects
Monkey PET Scan with [11C]-ART27.13
while minimizing CNS mediated toxicity Brain: Plasma Ratio = 0.5
CANCER / ANOREXIA CLINICAL PROGRAM
• Compelling development profile established in five
well-controlled clinical studies
• Artelo is planning for the next clinical study in
cancer patients with anorexia
• Upside potential from direct anti-cancer activity is 0 20 kBq/cc
also being evaluated in pre-clinical studies
Image adapted from: Schou M. et. Al. Radiolabeling of the cannabinoid receptor agonist AZD1940 [ART27.13] with carbon-11 and PET microdosing in non-human primate. (2013) Nuclear Medicine and Biology 40 410-414
12ART27.13 - Established Clinical Profile with Potential in Anorexia and Cancer
ART 27.13
• Dose-related weight gain observed in Phase 1 trials
• Desired activity (weight gain) observed with AE profile similar to placebo
• Weight loss among most common side effects of cancer treatment
CANCER / ANOREXIA CLINICAL PROGRAM
• Artelo to initiate Phase 1b/2a in anorexia (loss of appetite) associated with cancer in 2019
• Cannabinoid agonists show anti- proliferative potential for multiple cancers based on established
sensitivities
▪ Application for multiple potential cancers based on sensitivity to cannabinoids, including breast,
lung, skin, prostate, blood cancers, and pancreatic
▪ Preclinical studies show activation of CB1 and CB2 leads to tumor shrinkage, cell killing and
reduction in metastasis
▪ Artelo currently conducting cell line screening to determine best tumor candidate for a clinical
study in 2019
13ART27.13 – Exposure & Weight Gain Correlation Observed in a Phase 1 Study
ART 27.13
(125-250 μg)
Multiple ascending dose (MAD)
clinical study results over 12 days
CANCER / ANOREXIA CLINICAL PROGRAM
• 25% of subjects gained 3% or
greater of baseline body weight
• Acceptable side effect profile at Observed slope is significantly different from flat line (p=0.0001).
the intended low dose
(125-250 μg)
Source: Data on file
14ART 26.12 FABP5 INHIBITOR
ART26.12 – Endocannabinoid Modulator Development Led to Cancer Discovery
• FABP5 is an intra-cellular protein that serves as a carrier for certain lipids, including
endocannabinoids and fatty acids
• ART26.12 is a small molecule FABP5 inhibitor developed at Stony Brook University and
exclusively licensed to Artelo that has the potential to treat an array of disorders
• Inhibition of FABP5 suppresses the growth and migration of breast and prostate cancers
ART 26.12
• Working with the team at Stony Brook, Artelo plans to be ready to initiate IND-enabling studies
in 2019
ART 26.12FABP5
FAB5 INHIBITOR
INHIBITOR
16FABP5 Inhibitor Decreases Tumor Growth in Prostate Cancer Model
ART 26.12
ART 26.12FABP5
FAB5 INHIBITOR
INHIBITOR
SBFI26 = ART26.12 Inhibitor SBFI26 suppresses the malignant progression of castration-resistant PC3-M cells by
competitively binding to oncogenic FABP5 W. Al-Jameel, Oncotarget, 2017, Vol. 8, (No. 19),
pp: 31041-31056
17COMPANY
Artelo’s Portfolio Approach to Modulating the ECS
Artelo is developing a portfolio of product candidates designed to modulate the ECS
with the potential of best-in-class compounds in each therapeutic strategy
COMPANY METHODOLOGY
Naturally
Occurring Artelo Biosciences
Cannabinoids
GW Pharmaceuticals
Endo-
Synthetic cannabinoid SpringWorks (Pfizer)
Cannabinoids Modulators
Corbus Therapeutics
Zynerba Pharmaceuticals
OUR COMPANY
Janssen
COMPANY
Arena Pharmaceuticals
19Building Shareholder Value
Creating Value with Potential 2 Commercialized (THC/CBD & CBD)
GW Pharmaceuticals (GWPH) 3 Phase 2
Best-in-Class Therapeutics $4.2B
1 Commercialized
Our novel programs, patent Insys Therapeutics (INSY) 1 Phase 3
$569M
portfolio, and proven team are the 1 Phase 2
4 Phase 1
foundation for significant value
2 Phase 2 (chewing gum and topical)
creation in a high-growth sector $151M Axim Biotechnologies Inc (AXIM) 1 Phase 1 (chewing gum)
11 Pre-clinical
1 CBD gel in 3 Phase 2
$148M Zynerba Pharmaceuticals (ZYNE) 1 THC Pro-Drug Patch
$93M InMed Pharmaceuticals Inc (IMLFF) 3 Pre-clinical
2 Phase 1 (cream and tablet)
OUR COMPANY
$34M OWC Pharmaceuticals (OWCP) 1 Pre-clinical
COMPANY
1 clinic ready synthetic cannabinoid agonist
$16M Artelo Biosciences (ARTL) 2 Pre-clinical (fast follower novel CBD and
proprietary endocannabinoid modulator)
Market Cap Data June, 2018 Number of programs and stage by HGI analysis of company websites/presentations June, 2018. Subject to change.
20Proven Leadership
EXECUTIVE MANAGEMENT BOARD OF DIRECTORS SCIENTIFIC COLLABORATORS
GREGORY GORGAS CONNIE MATSUI SAOIRSE O’SULLIVAN, PhD
Chair of the Board University of Nottingham, UK,
President & CEO, Director
Nominating & Governance Committee Chair Cannabinoid Research Expert
Biogen Idec, Chiron, Cetus, Upjohn
Biogen Idec, Wells Fargo, Board Chair Halozyme
STEVEN D. REICH, MD STEVEN KELLY ANDREW YATES, PhD
Chief Medical Officer Compensation Committee Chair UK Pharmacist, AstraZeneca
Pfizer, Ligand, Biogen, PAREXEL Carisma, Theracrine, Amgen, IDEC, Sanofi
PETER O’BRIEN DOUGLAS BLAYNEY, MD
STEVE LAVIOLETTE, PhD
SVP, European Operations, Director ASCO President, Stanford Cancer Center,
University of Western Ontario, Canada
HSBC, Driver & Labour Recruit, University of Michigan, NCI
Nursing Station
GEORGIA ERBEZ
Audit Committee Chair
Jefferies, Cowen, H&Q, Raptor Pharmaceuticals
OUR COMPANY
R. MARTIN EMANUELE, PhD
COMPANY
DuPont, Avanir, DaVita
21Company Capitalization
Markets: Symbol OTCQB: ARTL
Investor Contact
Market Cap (1) USD $14.3M
Ioana Hone
Shares Outstanding (2) 12,781,195 Investor Relations / Corporate
Communications
Office: 760-943-16891.760.943.1689
Warrants (2) 3,261,195 Email: ir@artelobio.com
Options (2) None
Restricted Stock (2) 520,000
Note: S-1 Registration was made effective for selling
stockholders May 30, 2018
Fully Diluted (2) 16,562,390
OUR COMPANY
(1) May 15, 2018
(2) May 11, 2018
COMPANY
(3) February 28, 2018
22Achieved & Near-Term Anticipated Milestones
EVENT EXPECTED TIMING
ART12.11 Discovered cocrystal and filed patent application ✔
ART26.12 Obtained world-wide exclusive license to FABP5 target and compounds ✔
Steven D. Reich, MD appointed Chief Medical Officer ✔
ART27.13 Cancer cell line screening results Q3 2018
ART12.11 Pre-IND meeting with FDA Q4 2018
ART12.11 Composition of Matter patent issues Q2/Q3 2019
ART27.13 Exercise option to full license Q1 2019
ART27.13 Initiate clinical study in anorexia associated with cancer 2H 2019
OUR COMPANY
ART26.12 Begin IND-enabling studies 2H 2019
COMPANY
23Investment Summary
Three novel programs
▪ Developing best-in-class therapeutics from leading edge science
▪ Portfolio approach to endocannabinoid system (ECS) modulation provides multiple “shots on goal”
High-growth sector
▪ Cannabis Biotech/Pharma Market is expected to surpass $20 billion by 2020
▪ Premium pricing potential within regulated and protected pharmaceutical market
Near-term catalysts
▪ Pre-clinical development milestones and initiation of clinical studies in 2019
Robust patent estate
▪ Comprehensive issued and pending intellectual property
▪ Broad claims assure meaningful market exclusivity
OUR COMPANY
Proven leadership team
▪ Unmatched combination of deep scientific insights, discovery research, and clinical experience
COMPANY
▪ Led by recognized experts in regulated drug development and global commercial management
24ADDITIONAL DATA
Cannabidiol’s Inherent Polymorphism Challenge for Drug Development
ART 12.11
▪ Polymorphism in pharmaceuticals refers to The molecular structure of the two independent molecules
of cannabidiol (CBD), with the atom labelling, indicating
the ability of a solid material to exist in two inherent polymorphism of CBD
or more crystalline forms
▪ Polymorphic forms typically differ in their
PROPRIETARY COCRYSTAL CBD PROGRAM
physicochemical properties and exhibit
differences in pharmacological properties
including absorption rate and overall
bioavailability
▪ “Polymorphism can affect the quality,
safety, and efficacy of the drug product.”(1)
▪ A drug based on a specific polymorphic form
or with reduced polymorphism is likely to
have an improved safety and efficacy profile
(1) Andre S. Raw, Director- Division of Chemistry I FDA-CDER-Office of Cannabidiol revisited: T. Mayr, T. Grassl, N. Korber,a V. Christoffelb and M.
Generic Drugs Regulatory Consideration on Pharmaceutical Solids: Bodensteinerc, IUCrData (2017). 2, x170276
Polymorphs / Salts and Cocrystals https://doi.org/10.1107/S2414314617002760
26ART 12.11 and Native CBD Compared Using X-Ray Pattern Diffraction
ART 12.11
Cocrystal shows distinct pattern compared to native CBD indicating a new polymorph, while pharmacologically remaining CBD
PROPRIETARY COCRYSTAL CBD PROGRAM
Native CBD
ART 12.11*
*ART12.11 X-ray Pattern Diffraction 3x
27Potential for Cannabinoid Agonists for Anorexia and Cancer
ART 27.13
• Multiple cannabinoid agonists are already
approved in the US and some other major
markets for the treatment of nausea and
vomiting related to cancer chemotherapy
CANCER / ANOREXIA CLINICAL PROGRAM
• Clinical studies with cannabinoid agonists
have evaluated the potential for
cannabinoids to be used for anorexia and
cachexia associated with cancer
• 1500 peer review articles demonstrated
anti-tumor effects of cannabinoids in
multiple different cancer types
Literature CB1 and/or CB2 directed anti-tumor activity demonstrated in 1) ex-vivo, 2) in-vitro, 3) in-vivo, 4) human epidemiology 5) human clinical data.
Future Estimates for total worldwide sales in cancer types obtained from Developments in Cancer Treatments, Market Dynamics, Patient Access and Value
Global Oncology Trend Report 2015 IMS.
28History of ART 27.13
ART 27.13
2005 2012 2017-Current
AZD1940 NEO1940 ART27.13
▪ Developed at AstraZeneca: AZN ▪ IP transferred to The NEOMED ▪ Artelo fully-negotiated
CANCER / ANOREXIA CLINICAL PROGRAM
(NYSE) Institute option to trigger full license in
▪ 5 clinical trials conducted in pain ▪ Significant effect on weight Q1 2019
observed at the doses where CNS ▪ Clinic ready for Phase 2
▪ Administered orally in 205
side effect profile was similar to
humans and its safety, ▪ Cancer cell-line screening
placebo led to development plan
tolerability, pharmacokinetics and research for potential
in cachexia
pharmacodynamics investigated indication as anti-tumor agent
▪ Suitable for once-daily dosing
▪ Excellent pharmacokinetic ▪ Target indications:
properties Anorexia
▪ Limited brain access, Cancer
consequently a better CNS risk
profile compared to other
available cannabinoid agonists
29Supportive Activity Data for CB1/CB2 Agonists as Anti-Tumor Agents
ART 27.13
• Synthetic cannabinoids have anti-tumor
effects as a monotherapy
• Effects are blocked by cannabinoid
CB1 Effect CB2 Effect antagonists
CANCER / ANOREXIA CLINICAL PROGRAM
• Driven by both CB1 and CB2 effects
• >50% inhibitory effects observed for cell
killing, tumor shrinkage and reduction in
metastasis
• JWH (CB2) and Win (CB1) are not suitable
for the clinic and very few dual CB1/CB2
agonists have been designed to be
peripherally restricted; reducing potential
CNS side effects
Cancer Prev Res (Phila) . 2011 January ; 4(1): 65–75.
30ART26:12 Endocannabinoid Modulator with Potential for Multiple Indications
▪ Highly-selective, highly-potent FABP5 inhibitor created at Stony Brook University (NY)
▪ Nearly $4M invested via NIH grants
▪ Two promising applications:
▪ Novel and exciting mechanism of modulating the endocannabinoid system
▪ New approach to cancer treatment as FABP5 overexpressed in many cancers
ART 26.12
▪ Potential for indications in pain, inflammation, and cancer
ART 26.12FABP5
▪ Entering IND-enabling studies in 2019
FAB5 INHIBITOR
INHIBITOR
31FABP5 and the Endocannabinoid System
• Overexpression of FABP5 increases the hydrolysis
of anandamide (AEA)
• FABP5 inhibition decreases AEA hydrolysis
• FABP5 inhibition increases AEA levels
• Alternative mechanism to increase
endocannabinoid tone
ART 26.12
• FABP5 inhibition leads to CB1-mediated analgesia
ART 26.12FABP5
FAB5 INHIBITOR
INHIBITOR
32FABP5 is a Validated Target for Cancer Drug Development
▪ FABP5 delivers fatty acids to the
nucleus to activate PPARβ/δ and
PPARγ
▪ Activation induces cell growth,
ART 26.12
survival genes, and angiogenic
factors
ART 26.12FABP5
FAB5 INHIBITOR
INHIBITOR
Forootan et al., 2016 Oncotarget vol 7, no. 8 p9322-9339
33FABP5 is Upregulated in Breast, Prostate, and Cervical Cancer
In cancer patients, FABP5 is upregulated, correlates with tumor grade, and is associated with poor prognosis
Genetic silencing of FABP5 is anti-tumor
ART 26.12
ART 26.12FABP5
FAB5 INHIBITOR
INHIBITOR
Data above from breast cancer. Liu et al., 2011; Levi et al., 2013; Powell et al., 2015; Guaita-Esteruelas et al., 2017. Similar findings Powell et al., 2015 Oncotarget vol 6, no. 8 p6373-6385
published in prostate and cervical cancer. Forootan et al., 2010; Jeong et al., 2012.
34For more information: www.artelobio.com
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